Bioequivalence and Bioavailability Forum • No way! But...

No way! But... [Design Issues]

posted by PharmCat – Russia, 2019-12-07 00:46 (1987 d 21:08 ago) – Posting: # 20954
Views: 9,276

Hi all!

❝ Correct. If we would be allowed (pun!) to use a mixed-effects model. Patterson and Jones argued against this doubtful practice and the ethical implications of discarding data.

Really, there is no problem in mixed model approach to use all data if model constructed correctly. May be not all regulatory bodies can understand how it works - it is not rare situations when I get issue like "Give me ANOVA!!! I don't want to see your GLM or MIXED...", pfff... or "In guideline ***(any ancient as mammoth's excrement guideline) written ratio of geometric means - please just divide one to another and give me CI"... So here two answers - theoretically there is no problem to use all data, but regulatory authorities can bann you for it. (IMHO)

Complete thread:

Should those subjects have only one period data be included in BE analysis? ssussu 2019-12-06 10:58 [Design Issues]
- No way! But... Beholder 2019-12-06 12:36
  - No way! But... ElMaestro 2019-12-06 13:14
    - No way! But... Helmut 2019-12-06 14:47
      - No way! But...PharmCat 2019-12-06 23:46
        
        No way! But... wienui 2019-12-07 04:01
        
        EMA guideline: no way...: mittyri 2019-12-07 20:58
        
        EMA guideline: no way...: wienui 2019-12-09 05:25
        
        Slightly off topic, but related :-) ElMaestro 2019-12-08 01:31
        
        Slightly off topic, but related :-) Shuanghe 2019-12-09 12:00
        Slightly off topic, but related :-) PharmCat 2019-12-09 15:13
        
        Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
        
        Slightly off topic, but related :-) PharmCat 2019-12-22 01:12
        2.220446e-16 ≈ 0 Helmut 2019-12-22 10:37
        
        The optional tolerance argument ElMaestro 2019-12-23 14:37
        2.220446e-16 ≈ 0 PharmCat 2019-12-24 14:18
        
        Sum of residuals ~ ε Helmut 2019-12-24 14:54
        
        Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
        
        Wrong terminology Helmut 2019-12-28 13:55
        
        Sum of residuals ~ ε PharmCat 2019-12-24 18:40